Control the 4Ms – Man, Machinery, Method & Materials

In life sciences and highly regulated industries, real-time entry recording of 4Ms is inevitable. It enhances business process. 

You can save a lot of time and effort by digitalizing batch production records. Electronic Batch Record (EBR) System gives you complete control on the 4Ms. CaliberBRM reduces inventory wastage, checks and aligns manpower as per need, deals with instrument management, reduces review cycle time, etc. It in turn reduces operating costs.

Control the 4Ms – Man, Machinery, Method & Materials

In life sciences and highly regulated industries, real-time entry recording of 4Ms is inevitable. It enhances business process. 

You can save a lot of time and effort by digitalizing batch production records. Electronic Batch Record (EBR) System gives you complete control on the 4Ms. CaliberBRM reduces inventory wastage, checks and aligns manpower as per need, deals with instrument management, reduces review cycle time, etc. It in turn reduces operating costs.

Accelerate Batch Release with Review by Exception

Quality Review Management (QRM) stresses on performing Review by Exception to accelerate batch release. In manual batch record management process, human intervention is at highest leading to slower and riskier approach. 

When automation of BRM happens, review and approval of exceptions due to some deviations in process or OOS, etc. only can be done to save time. Reduce the review time and accelerate batch release with CaliberBRM system. 

Accelerate Batch Release with Review by Exception

Quality Review Management (QRM) stresses on performing Review by Exception to accelerate batch release. In manual batch record management process, human intervention is at highest leading to slower and riskier approach. 

When automation of BRM happens, review and approval of exceptions due to some deviations in process or OOS, etc. only can be done to save time. Reduce the review time and accelerate batch release with CaliberBRM system. 

Do It Right First Time

Do It Right First Time or RFT emphasizes on reducing the burden of wastage by focusing on 4Ms with electronic batch record software.

The concept essentially looks at validation of

  • production personnel’s skills,
  • calibration of instruments,
  • validation of raw materials, and
  • adherence to production methods or SOPs before batch production begins.

CaliberBRM focuses and opens more avenues for accelerating batch release, reducing batch recalls, and increasing company revenues.

Do It Right First Time

Do It Right First Time or RFT emphasizes on reducing the burden of wastage by focusing on 4Ms with electronic batch record software.

The concept essentially looks at validation of

  • production personnel’s skills,
  • calibration of instruments,
  • validation of raw materials, and
  • adherence to production methods or SOPs before batch production begins.

CaliberBRM focuses and opens more avenues for accelerating batch release, reducing batch recalls, and increasing company revenues.

In-line with Global Regulations

Regulatory bodies like FDA, MHRA, TGA, Health Canada, EMEA, and others always stress on continuous improvement in product and process quality. 

CaliberBRM ensures quality by design (QBD) and is in-line with global regulations. You can adhere to all regulatory guidelines and produce standard quality products at all times. 

In-line with Global Regulations

Regulatory bodies like FDA, MHRA, TGA, Health Canada, EMEA, and others always stress on continuous improvement in product and process quality. 

CaliberBRM ensures quality by design (QBD) and is in-line with global regulations. You can adhere to all regulatory guidelines and produce standard quality products at all times. 

CaliberBRM, A Complete Batch Manufacturing Solution

Possibility of multiple applications and modules integrations at a time for seamless quality experience makes
CaliberBRM a complete manufacturing solution.

Automate Batch Production Logbooks

One of the independent modules of CaliberBRM, CalibereLog automates batch manufacturing logbooks. It reduces human errors, data security and compliance issues, etc. for smooth execution of production processes.

 

Integration with Engineering Services Management System

CaliberESM assists you in achieving a quality system approach for Facilities and Equipment. You can manage end-to-end equipment lifecycle by integrating CaliberBRM with CaliberESM.

 

Regular In-process Quality Checks

In-process quality checks are checks carried out to assess product quality while the batch manufacturing process is still in progress. An independent module of CaliberBRM, it helps in streamlining the process and complying with the specifications.

Automating Manufacturing Excellence

CaliberBRM’s Integration with Anmeda Solutions has provided an edge to deal with various PLCs. Anmeda  develops communication software for different automation hardware and its integration with CaliberBRM ensures free data flow.

Integration with ERP, Instruments, & Other Applications

Integration with DMS, QMS, CMS, ERP, instruments and other internal and external applications is easily performed with CaliberBRM. Seamless integration ensures automatic one-way and two-way flow of data ensuring a very few errors and better quality.

One of the independent modules of CaliberBRM, CalibereLog automates batch manufacturing logbooks. It reduces human errors, data security and compliance issues, etc. for smooth execution of production processes.

 

CaliberESM assists you in achieving a quality system approach for Facilities and Equipment. You can manage end-to-end equipment lifecycle by integrating CaliberBRM with CaliberESM.

 

In-process quality checks are checks carried out to assess product quality while the batch manufacturing process is still in progress. An independent module of CaliberBRM, it helps in streamlining the process and complying with the specifications.

CaliberBRM’s Integration with Anmeda Solutions has provided an edge to deal with various PLCs. Anmeda  develops communication software for different automation hardware and its integration with CaliberBRM ensures free data flow.

Integration with DMS, QMS, CMS, ERP, instruments and other internal and external applications is easily performed with CaliberBRM. Seamless integration ensures automatic one-way and two-way flow of data ensuring a very few errors and better quality.

Key Product Highlights

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Master Batch Record (MBR)

The Master Batch Record is configurable for any given product and batch size (fixed & variable) by creating reusable batch record templates for every activity of the process.

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CEBR

The batch record execution can be automated by online process of CEBR or alternatively, an offline process can be initiated by the print of master batch record.

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Material Weighing and Dispensing

The material dispensing and receiving can be performed with or without instrument interface, with label printing functionality and a check for dispense quantity.

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Electronic Log (eLog)

eLog of CaliberBRM tracks and generates reports for operational and non-operational activities including Area Usage, Equipment Usage, Report Configuration, etc.

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E-checklist

An important feature of CaliberBRM, E-checklist is a simple functionality of automated checklist. It is also known as paper on glass.

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Simple Batch Closure Process

All the executed templates will be displayed during batch closure and the user can close the batch at any stage in CaliberBRM.

Lesser Batch Wastage and More Profitability with CaliberBRM

  1. Ensure quick turn around time by reducing the time and effort spent by personnel in manual maintenance of batch records. Accelerates batch release time and ensures good ROI
  2. Save paper by turning to cost-effective paperless manufacturing system. The one-time investment reduces all the paper-based manufacturing risks
  3. EBR software reduces costs of maintenance, printing, issuance, and storage of batch records, log books and other paper records. It ensures substantial savings in annual investments

Automate your Batch Manufacturing to ensure compliance, attain data integrity, and achieve much more.

Lesser Batch Wastage and More Profitability with CaliberBRM

  1. Ensure quick turn around time by reducing the time and effort spent by personnel in manual maintenance of batch records. Accelerates batch release time and ensures good ROI
  2. Save paper by turning to cost-effective paperless manufacturing system. The one-time investment reduces all the paper-based manufacturing risks
  3. EBR software reduces costs of maintenance, printing, issuance, and storage of batch records, log books and other paper records. It ensures substantial savings in annual investments

Automate your Batch Manufacturing to ensure compliance, attain data integrity, and achieve much more.

Trusted by Industry Leaders

Quality Achievers trust Caliber.

Implementation of Caliber software has given us better confidence to face regulatory inspections. The execution was systematic, training was excellent, and service… Milan
CaliberBRM stands tall on the issues of Data Integrity & ALCOA, complying to all Regulatory requirements, and is a bliss for QA… JB Chemicals

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